BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER

    MDR report key: 3190736 · Received June 24, 2013

    Report

    Report Number
    2939520-2013-00026
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K080891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT WAS INFECTIOUS. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIAL. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR A SIMILAR FAILURE MODE WITHIN THIS LOT. DEVICE EVALUATION WAS NOT POSSIBLE AS THE CATHETER WAS NOT RETURNED FOR EVALUATION. THERE WERE NO REPORTS OF PT INJURY OR ADVERSE EVENTS DUE TO THIS INCIDENT. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN OBSERVED THE IVUS CATHETER SHAFT TO BE SEPARATED UPON REMOVAL OF THE CATHETER OUTSIDE THE BODY AFTER SUCCESSFULLY COMPLETING THE PCI AND IVUS PROCEDURES. THE PHYSICIAN REPORTED THAT ALL PORTIONS OF THE IVUS CATHETER WERE ACCOUNTED FOR WHEN REMOVED AND NO ADDITIONAL INTERVENTION WAS REQUIRED. IT WAS REPORTED THAT THE VESSEL WAS NOT TORTUOUS AND THERE WAS NO CALCIFICATION. THE PHYSICIAN DID NOT EXPERIENCE ANY RESISTANCE DURING THE PCI AND IVUS PROCEDURES. NO PT INJURY OR ADVERSE EVENTS OCCURRED DUE TO THIS INCIDENT AND THE PT WAS RELEASED FROM THE HOSPITAL ACCORDING TO THE ORIGINAL TREATMENT PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286392 REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 89000 035 05566

    Patients

    Seq Age Sex Outcome Treatment
    1